Health Canada Issues Guidance for Registration and Results Disclosure of Canadian Clinical Trials

On July 29, 2026, Health Canada published its Guidance on the Registration of Clinical Trials and Public Disclosure of Results (the “Guidance”), setting out policy expectations for Canadian clinical trial registration and public disclosure of results. The expectations set out in the Guidance are consistent with the principles of the World Medical Association’s Declaration of Helsinki and standards put forth by the World Health Organization (“WHO”). The publication of the Guidance also accompanies the launch of the Canadian Clinical Trial Search Portal, which replaces the previous Clinical Trial Database.

Although the Guidance does not have the force of law, Health Canada presents it as a step toward a future mandatory clinical trials transparency regime. Clinical trial sponsors should take note and assess their clinical trial registration and result disclosure procedures, as Canada continues to align with international expectations for clinical trial transparency.

Which Clinical Trials Are Covered by the Guidance?

The Guidance applies to sponsors of clinical trials regulated under Canada’s Food and Drugs Act and its regulations, including phase 1, 2 and 3 clinical trials for development of drugs and natural health products (“NHPs”), and investigational testing of Class II–IV medical devices.

The Guidance does not apply to comparative bioavailability studies, open-label individual patient trials, Phase 4 trials for drugs or NHPs used within the parameters of their marketing authorization, or trials for Class I devices used within the parameters of their marketing authorization.

What Are Sponsors Expected to Do?

The Guidance sets out two key expectations for sponsors of Canadian clinical trials:

1. Clinical Trial Registration

Sponsors are expected to register each clinical trial in a WHO-compliant registry, such as clinicaltrails.gov or the ISRCTN registry, ideally before enrolment begins in Canada but no later than 21 days after the first participant is enrolled. For multi-national trials with one or more Canadian sites, sponsors are expected to add the Canadian site(s) to the existing registry ideally before enrolment but no later than 21 days after enrolment of the first participant at the Canadian site(s). Clinical trial registration is not done with Health Canada directly.

2. Public Disclosure of Summary Results

Sponsors are expected to post summary results in the same registry within 12 months of primary study completion, meaning the final study visit for data collection on all the primary outcome measures for the last participant in the global study. The expected information follows WHO standards, including participant flow, baseline characteristics, outcome measures, and adverse events, but does not include individual patient data.

Where a sponsor intends to apply for market authorization, disclosure of summary results may be deferred until the earlier of 30 days after Health Canada renders a decision (or the sponsor withdraws its application), and 36 months after primary study completion. The timeframe for deferred reporting is intended, in part, to minimize potential disadvantages to disclosing information before a product has market authorization. However, Health Canada does not support deferral where the sponsor does not intend to market or where product development has stopped.

What Is the Canadian Clinical Trial Search Portal?

Health Canada’s search portal is not a clinical trial registry, but rather a searching tool for clinical trials approved by Health Canada involving human pharmaceutical, biologic and radiopharmaceutical drugs. The search portal provides only select bibliographic information about each trial, which is collected directly from the clinical trial registry where the sponsor has already provided information about the trial (e.g., clinicaltrails.gov), and includes a link to that registry for the trial.

The Guidance does not require sponsors to provide any information to Health Canada for purposes of maintaining its search portal.